IntubationNCT05819645
Oral Fluid Intake After Extubation
A study testing Fluid intake not as per standard guidlines in people with Intubation, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation
- What is being tested?
- Fluid intake not as per standard guidlines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2023to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with planned extubation assigned to the study
- able to swallow the fluid
- willing to participate the study
Who cannot join
- patients after upper digestive tract surgery
- patients after trachea surgery
- patients with possible neurological deficiency
- patients after VIII. cranial nerve surgery
- patients not able to swallow
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Motol, Charles University in Prague
Prague, Czech Republic, 15006
About this study
Official title: Early Versus Delayed Oral Fluid Intake Initiation (Sipping) After Extubation, Influence on the Feeling of Thirst, Patient Comfort and the Occurrence of Complications.
According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Because anaesthetic drugs and their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine. Keeping patient n.p.o (nothing per os) for 2 hours after extubation may lead to patient´s thirst or other discomfort. The aim of the study is to detect whether early oral fluid intake after extubation could lead to safe relief of thirst and to better patient´s comfort overall.
Read the detailed description
Everything stated in the brief summary.
- Conditions
- Intubation
- Being tested
- Fluid intake not as per standard guidlines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid intake not as per standard guidlinesBehavioural
The participant will be randomized into two arms. After the randomization one arm will get the per os fluid intake before the standard time frame.
| Study group | Role | What they receive |
|---|---|---|
| Early fluid intake | Experimental | Not described Receives: Behavioral: Fluid intake not as per standard guidlines |
| Standard Delayed oral fluid | Other | Not described Receives: Behavioral: Fluid intake not as per standard guidlines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of presence or absence of thirst 120 minutes after extubation
Between both groups the presence of anpleasent feeling of thirst will be assessed and compared
Measured: During procedure (120 minutes after extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Feb 2023
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819645
- Sponsor's protocol ID
- EK-1381/22
- Status last verified
- Oct 2024
- First submitted
- 6 Jan 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sedlackova S, Nigrovicova V, Peckova M, Durila M. Immediate "sipping" vs. delayed oral fluid intake after extubation: A randomized controlled trial. J Crit Care. 2026 Feb;91:155212. doi: 10.1016/j.jcrc.2025.155212. Epub 2025 Aug 7.
PubMed 40780083
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Oral Fluid Intake Initiation (Sipping) After Extubation, Influence on the Feeling of Thirst, Patient Comfort and the Occurrence of Complications.
- ClinicalTrials.gov ID
- NCT05819645
- Acronym / sponsor ID
- EK-1381/22
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Because anaesthetic drugs and their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine. Keeping patient n.p.o (nothing per os) for 2 hours after extubation may lead to patient´s thirst or other discomfort. The aim of the study is to detect whether early oral fluid intake after extubation could lead to safe relief of thirst and to better patient´s comfort overall.
Detailed description
Everything stated in the brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early fluid intake | Experimental | Behavioral: Fluid intake not as per standard guidlines |
| Standard Delayed oral fluid | Other | Behavioral: Fluid intake not as per standard guidlines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with planned extubation assigned to the study
- able to swallow the fluid
- willing to participate the study
Key exclusion criteria (5 listed)
- patients after upper digestive tract surgery
- patients after trachea surgery
- patients with possible neurological deficiency
- patients after VIII. cranial nerve surgery
- patients not able to swallow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid intake not as per standard guidlinesThe participant will be randomized into two arms. After the randomization one arm will get the per os fluid intake before the standard time frame. | Behavioural | Early fluid intake, Standard Delayed oral fluid |
Primary outcome
Assessment of presence or absence of thirst 120 minutes after extubation
Time frame: During procedure (120 minutes after extubation)
Between both groups the presence of anpleasent feeling of thirst will be assessed and compared
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Derived from this study: PubMed 40780083Sedlackova S, Nigrovicova V, Peckova M, Durila M. Immediate "sipping" vs. delayed oral fluid intake after extubation: A randomized controlled trial. J Crit Care. 2026 Feb;91:155212. doi: 10.1016/j.jcrc.2025.155212. Epub 2025 Aug 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid intake not as per standard guidlines in people with Intubation, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of presence or absence of thirst 120 minutes after extubation (time frame: During procedure (120 minutes after extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.